Obesity Capsule From Gelesis, Made to Swell Up in the Stomach, Passes First Human Trial

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There must be a million ideas to help the many millions of obese Americans lose weight. Today, doctors will get a glimpse at a first-of-its-kind treatment from Boston-based Gelesis, where scientists have created a capsule that expands in the stomach to make people feel full and eat less.

Gelesis has said little about this idea since the company was founded with seed financing from Puretech Ventures, plus another $16 million from OrbiMed Advisors, Queensland BioCapital Funds, Puretech, and others in January 2008. Now Gelesis has results from a clinical trial of 95 people who were randomly assigned to take the company’s superabsorbent hydrogel capsules (Attiva) or a placebo. The capsules helped people feel full after meals and less hungry in between, researchers said. And, importantly, the treatment was well-tolerated. The findings were presented at the American Association of Clinical Endocrinologists annual meeting in Boston.

Anyone following the news knows that the obesity epidemic in the U.S. has gotten so big that it poses a threat to the healthcare system, and, simultaneously, represents a monster business opportunity. Health officials now say two-thirds of U.S. adults have become overweight or obese, which raises the risk for a whole raft of other conditions like diabetes, heart attacks, and depression to name a few. Doctors often advise people to eat healthier and exercise more, without much luck. A few biotech companies are racing to win FDA approval of new drugs, but Big Pharma companies have tread cautiously in this field since the fen-phen debacle of the ’90s. Gastric bypass surgery to shrink the stomach can help people, although the procedure carries significant risks.

Alessandro Sannino

The idea at Gelesis is to come at this problem with a completely new method. It’s essentially a way to reduce stomach volume without subjecting people to the invasiveness and potential complications of surgery.

“For the first time a group was able to overcome the enormous technical hurdles in creating a super-absorbent polymer,” said Robert Langer, the prominent bioengineering professor at MIT, in a company statement. Langer isn’t a founder of the company, although he advised Puretech Ventures on the technology before the firm seeded Gelesis in 2006. Based on today’s results, Langer added: “This opens the door for entirely new uses of polymers in medicine.”

I took a closer look at this yesterday during a conference call with three key players of Gelesis. Daphne Zohar and Eric Elenko of Puretech Ventures, and the co-inventor of the technology, Alessandro Sannino, a professor of engineering at the University of Sallento in Italy, who has been working on this idea for 15 years. The company also has recruited a lot of prominent advisers with different layers of expertise. James Hill, a University of Colorado professor and past president of The Obesity Society brings obesity knowledge; Allan Geliebter, a phychologist at St. Luke’s-Roosevelt Hospital is a pioneer of the gastric balloon; Lee Kaplan of Massachusetts General Hospital Weight Center is a leading researcher in gastric bypass surgery. John LaMattina, a former president of Pfizer’s global R&D operation, has joined the Gelesis board.

You can take a look at how this technique is supposed to work by watching this animation on the Gelesis site, which lasts a little less than four minutes. But’s here the concept in a nutshell: Gelesis has developed a superabsorbent polymer from some unspecified food source. This material, about the size of a grain of sugar, is designed to swell up more than 100-fold … Next Page »

I’ve also invented a way to lower the obesity “epidemic”. Its called eating healthy food and exercising. I know, it sounds crazy, but it works. Here is a complex equation to demonstrate the above.
Calories Gain – Calories Used = Fat burnt

Do the polymer molecules actually degrade? If not, won’t this produce another constant stream of plastic molecules entering and polluting the oceans? For problems with the plastic in the oceans see algalita.org.

It seems unlikely that people will be able to stop using this once they start because they’ll become accustomed to always feeling full.

Can anyone tell me if Attiva is available yet to the general public? I just cam across a site that offers a similar product call FORM and wonder if this is the same thing.

http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

Razele–no, Attiva is not available on the market.

Razele Warren

I am very interested in this product. However, I worry about its safety. Particularly, on whether there have been any studies on rats that show no cancer after long-term use? I make this comment on the basis of silicon breast causing cancer.

Razele Warren

Can anyone tell me whether Attiva will be available as either a prescription or non-prescription.

Also, can anyone tell me when Gelesis will re-present to the FDA again. I’m growing fatter by the day.

Thomas Aquino

A year an five months have gone by since this article was published. It is old news. Any news about the second trial?

Razele Warren

How much longer do we need to wait before this is made available. I mean, what else does Gelesis need to be do? Is there a second trial in the pipeline?

Val Jacobs

Just wondering what precautions are being taken for those who have a difficult time swallowing pills should one of the “edible water beads” get stuck in the throat and start swelling before it reaches the stomach?

Second point, perhaps should have been the first, people who overeat do not stop eating when they feel full, otherwise they wouldn’t have become overweight in the first place. Will the stomach lose its capacity to stretch because these water beads are inside instead of food?

xoom

Any updates on this product?

I’m trying to understand how a product of this nature is taking so long to reach market? It’s NOT absorbed into the bloodstream; therefore, it can’t be considered a pharmaceutical product. It’s mechanical in nature, so it can’t be governed by the same, strict, FDA regulations that apply to systemic drugs like Qnexa, and it’s certainly not the first product of its kind. Appesat expands in the stomach (albeit poorly) and it’s available today. The precedent for this series of products is set, so why is Gelesis f**king the dog?

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Excellent studies and informaiton. I hope to try this out when its made available!